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Manager, Biostatistics


Collegeville, PA 19426
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Job Details

Design, analyze, and interpret clinical trials and/or observational studies in compliance with relevant

regulatory requirements, Pfizer standards and best practices.

Provide scientifically rigorous statistical expertise and contributions by working effectively within the

clinical triad (clinician, clinical pharmacologist, and statistician), co-owning the EQDD plan, or by

partnering with other stakeholders (e.g., Global Health and Value):

- on projects and protocols in support of clinical development and for publication, presentation,

access negotiation, and other evidence generation efforts for Pfizer products.

- on regulatory and HTA submissions, ensuring quality and appropriateness of submission


- on projects to maximize the value of aggregate clinical and real world data in support of drug

development and other scientific strategies.

Provide study and other project level statistical counsel and communicate resource needs to teams.

**Primary Duties:**

Provide scientifically rigorous statistical input into study design, statistical analysis plans,

interpretation of statistical results, project development plans, regulatory issues and scientific and

other product support projects.

Provide planning, delivery and communication of statistical analyses, data presentations, and

scientific reports, including clinical trial results, exploratory and meta-analysis results **,** support for

publication activities **,** scientific presentations, and support to product defense.

Be accountable for study or project level and submission level statistical deliverables on assigned projects.

Be accountable for implementation of quality, productivity and other best practices, including coownership

of EQDD plans, in close collaboration with other triad members or stakeholders.

Develop effective collaborations with others within clinical teams and/or GH&V colleagues, partner

lines (such as, DevOps, PharmSci, SRM, Regulatory), and external regulatory, payer, industry,

professional and academic organizations.

Ensure that all study and project level statistical activities are conducted in compliance with relevant

regulatory requirements and Pfizer standards.

Be up-to-date on SOP training and compliance with all Pfizer SOPs as required based on the

assigned curriculum.

Provide statistical input and leadership to cross-functional activities - collaborate with other

statisticians, study managers, CII colleagues - for assigned studies or regulatory and Health

Technology Assessment (HTA) submissions.

Provide input to the Statistics Group Lead or TA Statistics Head to plan support for assigned studies

and submissions.

Ensure timeliness and quality of statistical deliverables according to project plans for assigned studies

and projects.

Comply with all statistics and quality processes, Pfizer data standards that are applicable to statistical

outputs, and support processes that require statistical input.

Communicate and collaborate with other project statisticians within the unit, or other units where

applicable, to ensure consistency of statistical approaches across studies and alignment with

approaches used in phase III regulatory submissions.

Provide a strong statistical presence in regulatory and professional circles to influence content of

regulatory guidelines and their interpretation in practice.

Participate in research on statistical methodology and its applications pertinent to the Pfizer business


Help maintain a strong statistics community at Pfizer through collaborations, scholarship,

presentations and learnings across divisions.

**Training & Education**

Advanced degree in statistics, biostatistics, or related field.

Relevant clinical trial, real-world data and business experience providing an understanding of the

processes associated with clinical, regulatory and marketing operations.

Capability to provide statistical leadership to cross -functional teams at the protocol or project level.

Strong statistical skills with application to clinical trials and/or analysis of observational studies.

Effective verbal and written communication skills in relating to colleagues and associates both inside

and outside the organization.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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